MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH; OFF SHLDR GPS BLOCK R

Catalog Number	531-01-04
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
It was reported the base of the patient¿s coracoid bone was fractured.Most likely from the screws used to attached the ¿g¿ tracker onto the coracoid.This was discovered prior to drilling the compression screws into the reverse baseplate.There was no surgical delay.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
H10: (h3) the intraoperative coracoid fracture reported was likely the result of positioning the coracoid fixation pins during surgery.The contributions of patient bone quality, pin positioning, or inadvertent contact to the pinned coracoid block during surgery cannot be confirmed as the devices were not returned for evaluation and no additional information or radiographs were provided.

• Brand Name: EXACTECH
• Common Device Name: OFF SHLDR GPS BLOCK R
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10837228
• Report Number: 1038671-2020-00607
• Device Sequence Number: 3526222
• Product Code: LXH
• UDI-Device Identifier: 10885862527776
• UDI-Public: 10885862527776
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 531-01-04
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/23/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2020
• Supplement Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 12/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Weight: 77